Device for intraocular fluid injection
Devices and methods for intraocular fluid injection are disclosed. A device can include a surgical instrument for an ophthalmic procedure. The surgical instrument can include a handle. A fluid compartment can be coupled to the handle and configured to hold a substance. A tool can be coupled to the distal end of the handle and have a lumen configured to convey the substance into an intraocular site of a patient. A piston can be in the handle and configured to reciprocate along the longitudinal axis of the handle to draw the substance from the fluid compartment and eject the substance through the lumen of the tool. A push button can be on the lateral side of the housing and configured to engage the piston via a sloped surface to actuate a forward stroke of the piston towards the distal end of the handle.
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This application is a continuation of and claims priority to International Patent Application No. PCT/US2019/027358, filed Apr. 12, 2019, which claims the benefit of priority under 35 U.S.C. § 119 from U.S. Provisional Application No. 62/656,818, entitled “FLUID INJECTION FOR TRABECULECTOMY,” filed Apr. 12, 2018, the entirety of which is incorporated herein by reference.
TECHNICAL FIELDDisclosed embodiments relate in general to medical devices and procedures, and more particularly to a surgical instrument and method for intraocular fluid injection.
BACKGROUND OF THE DISCLOSUREGlaucoma refers to a group of eye conditions that cause damage to an eye's optic nerve, typically due to increased intraocular pressure (pressure in the eye). Millions of people suffer from glaucoma with symptoms that include vision loss, or in extreme cases, irreversible blindness.
The accompanying drawings, which are included to provide further understanding of the subject technology and are incorporated in and constitute a part of this description, illustrate aspects of the subject technology and, together with the specification, serve to explain principles of the subject technology.
The detailed description set forth below is intended as a description of various implementations and is not intended to represent the only implementations in which the subject technology may be practiced. As those skilled in the art would realize, the described implementations may be modified in various different ways, all without departing from the scope of the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.
Embodiments disclosed herein may be implemented as instruments or devices suitable for ophthalmic procedures, including, for example, devices having blades or other tools configured to cut or remove portions of tissue from a trabecular meshwork or other intraocular tissue. Some examples of such devices are disclosed in U.S. Non-Provisional application Ser. No. 15/791,204, filed on Oct. 23, 2017, and U.S. Non-Provisional application Ser. No. 15/389,328, filed on Dec. 22, 2016, the entirety of each of which is incorporated herein by reference. Embodiments disclosed herein may be implemented as devices having microcannulas or orifices configured to inject a substance into Schlemm's canal or other intraocular sites. Some examples of such devices are disclosed in U.S. Provisional Application No. 62/750,151, filed on Oct. 28, 2018, and U.S. Non-Provisional application Ser. No. 15/847,770, filed on Dec. 19, 2017, the entirety of each of which is incorporated herein by reference.
To facilitate the understanding of the present disclosure, a number of terms are defined below.
Terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the present disclosure. Terms such as “a,” “an,” and “the” are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration.
As used herein, the term “patient” or “subject” refers to a living mammalian organism, such as a human, monkey, cow, sheep, goat, dog, cat, mouse, rat, guinea pig, or transgenic species thereof. In certain embodiments, the patient or subject is a primate. Non-limiting examples of human subjects are adults, juveniles, infants and fetuses.
“Prevention” or “preventing” includes: (1) inhibiting the onset of a disease in a subject or patient which may be at risk and/or predisposed to the disease but does not yet experience or display any or all of the pathology or symptomatology of the disease, and/or (2) slowing the onset of the pathology or symptomatology of a disease in a subject or patient which may be at risk and/or predisposed to the disease but does not yet experience or display any or all of the pathology or symptomatology of the disease.
The term “therapeutically effective amounts” or “pharmaceutically effective amounts”, as used herein means that amount which, when administered to a subject or patient for treating a disease, is sufficient to effect such treatment for the disease or to ameliorate one or more symptoms of a disease or condition (e.g. ameliorate pain).
As used herein, the terms “treat” and “treating” are not limited to the case where the subject (e.g. patient) is cured and the disease is eradicated. Rather, embodiments of the present disclosure also contemplate treatment that merely reduces symptoms, improves (to some degree) and/or delays disease progression. It is not intended that embodiments of the present disclosure be limited to instances wherein a disease or affliction is cured. It is sufficient that symptoms are reduced.
As used herein “goniotomy” refers to a surgical procedure primarily used to treat various types of glaucoma (e.g., primary open angle glaucoma).
As used herein “trabecular meshwork” refers to area of tissue in the eye located around the base of the cornea, near the ciliary body, (between the scleral spur and Schwalbe's line) and is responsible for draining the aqueous humor from the eye via the anterior chamber (the chamber on the front of the eye covered by the cornea). The tissue is spongy and lined by trabeculocytes; it allows fluid to drain into a circular channel in the eye called Schlemm's canal and eventually flowing into the blood system.
As used herein “Schlemm's canal” refers to a circular channel in the eye that collects aqueous humor from the anterior chamber and delivers it into the bloodstream via the collector channels and anterior ciliary veins.
As used herein “eye diseases” refers to various conditions of the eye including, but not limited to Glaucoma—optic neuropathy, Glaucoma suspect—ocular hypertension, Primary open-angle glaucoma, Primary angle-closure glaucoma, primary open angle glaucoma, normal or low tension glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma, angle closure glaucoma (acute, subacute, chronic), neovascular or inflammatory glaucoma, ocular hypertension, and other types of glaucoma that are related to dysregulation of intraocular pressure.
As used herein “hypotony” refers to reduced intraocular pressure. The statistical definition of hypotony is intraocular pressure (“TOP”) less than 6.5 mmHg, which is more than 3 standard deviations below the mean TOP. The clinical definition of hypotony is TOP low enough to result in pathology (vision loss). The vision loss from low TOP may be caused by corneal edema, astigmatism, cystoid macular edema, maculopathy, or other condition. Hypotony maculopathy is characterized by a low TOP associated with fundus abnormalities, including chorioretinal folds, optic nerve head edema in the acute setting, and vascular tortuosity.
As used herein “Schwalbe's line” refers to the anatomical line found on the interior surface of the eye's cornea, and delineates the outer limit of the corneal endothelium layer. Specifically, it represents the termination of Descemet's membrane.
As used herein “Descemet's membrane” refers to the basement membrane that lies between the corneal proper substance, also called stroma, and the endothelial layer of the cornea.
As used herein “scleral spur” refers to an annular structure composed of collagen in the human eye, a protrusion of the sclera into the anterior chamber. It is the origin of the longitudinal fibers of the ciliary muscle and is attached anteriorly to the trabecular meshwork. Open-angle glaucoma (OAG) and closed-angle glaucoma (CAG) may be treated by muscarinic receptor agonists (e.g., pilocarpine), which cause rapid miosis and contraction of the ciliary muscles, this pulls the scleral spur and results in the trabecular meshwork being stretched and separated. This opens the fluid pathways and facilitates drainage of the aqueous humour into the canal of Schlemm and ultimately decreasing intraocular pressure.
As used herein “Trabectome®” refers to a minimally invasive glaucoma surgical electrosurgical or ablation tool for the surgical management of adult, juvenile and infantile glaucoma. Unlike a trabeculectomy, the surgery with a Trabectome® should not create an external filtering bleb or require leaving a permanent hole in the eye. Instead, the Trabectome® electro-surgical handpiece opens access to the eyes natural drainage system.
Minimally invasive surgical procedures involving ocular incisions and/or intraocular fluid injection can be useful for treating glaucoma and other eye conditions. For example, in a Trabeculectomy, a surgeon can use an ophthalmic blade inserted through an incision in the eye to remove a portion of the trabecular meshwork, thereby improving outflow of the aqueous humour (AH) and relieving intraocular pressure contributing to glaucoma.
During the removal of the trabecular meshwork using an ophthalmic blade, some cases have been observed in which minor bleeding occurs. When bleeding occurs during the surgery, the blood can cover up the trabecular meshwork and Schlemm's canal, creating a visual obstruct. One method of dealing with the blood reflux involves removing the ophthalmic blade from the eye and inserting a viscoelastic syringe. The viscoelastic syringe can be used to push the blood reflux back into the Schlemm's canal and collecting channels or move the blood away from the trabecular meshwork. Once the blood is pushed away from the trabecular meshwork, the viscoelastic syringe is removed from the eye and ophthalmic blade is re-inserted to continue the surgery.
Embodiments disclosed herein include medical instruments and related methods that may be used in an ophthalmological procedure without a need for inserting and removing a separate viscoelastic syringe when such bleeding occurs. The disclosed embodiments include, among other things, a surgical instrument having an ophthalmic blade and integrated fluid delivery mechanism for intraocular injection of a viscoelastic fluid. It will be appreciated that various embodiments and principles disclosed herein may additionally or alternatively be employed for other purposes or for other medical or surgical procedures.
Turning now to the figures,
Referring to
The handle 104 includes a housing 112 having a connector or interface for coupling to the fluid source 108. More particularly, the housing 112 includes a luer lock connector 128 configured to removably attach to a component of the fluid source 108, such as a syringe 124 and/or a pre-fill component 300 (
As shown in
As shown in
As shown in
As shown in
The interior cavity of the housing 112 includes one or more sealed chambers 164a,b that may be implemented as cylinders for compression and expansion by the piston 156. More particularly, the interior cavity of the housing 112 includes a pair of complementary chambers, including a fluid entry chamber 164a and a fluid exit chamber 164b disposed on opposing sides of the piston 156. The chambers are configured in a complementary fashion such that a compression stroke of the piston 156 for one of the chambers corresponds to an expansion stroke for the other chamber, and vice versa.
As illustrated, the entry chamber 164a may be sealed with an O-ring 168a disposed between a lateral exterior surface of the piston 156 and an interior surface of the cavity. The second chamber 164b may be sealed with an O-ring 168b disposed between a lateral exterior surface of the piston 156 and an interior surface of the cavity. More generally, in various embodiments either or both of the chambers 164a,b may be sealed using any of a variety of other appropriate seals or sealing elements.
The fluid transfer mechanism also generally includes a series of valves 172a-d and a fluidic channel 180 extending through the piston to facilitate compression, expansion, and transfer of the fluid within the mechanism as appropriate. As further described below, the fluid transfer mechanism may be designed to transfer fluid in a forward direction, from a proximal end to a distal end.
Referring to
An exit valve 172b is disposed at a fluid exit port of the exit chamber 164b, which corresponds to the position of the tool section 102 or a tool interface 116 configured to couple to a tool section 102. The tool interface 116 can be configured as a luer lock connector for coupling to a removable tool or provide a fixed fastening mechanism (e.g., welding, adhesives, screws, etc.) As shown in
One or more piston valves 172c,d are disposed on the piston 156 in a fluidic pathway extending through the piston 156. In particular, the piston 156 includes a channel 180 extending through it for transferring fluid from the entry chamber 164a to the exit chamber 164b, with one or more piston valves 172c,d disposed in the piston channel 180 or otherwise disposed in the fluidic pathway defined by the piston channel 180. Each of the piston valves 172c,d may be a check valve (or one-way valve) of a type that permits fluid flow across it in a forward direction, e.g., towards a distal side or in direction extending from the entry chamber 164a to exit chamber 164b, but prevents fluid flow across it in the opposite direction.
The piston channel 180 may optionally be segmented into a plurality of sub-channels, each terminating in a respective piston valve. For example, the piston channel 180 may include a first sub-channel terminating in a first piston valve that feeds fluid into a second sub-channel terminating in a second piston valve, and so forth. To facilitate manufacturing thereof, the piston 156 itself may be segmented into a plurality of components or pieces that are fixedly attached to one another, which may facilitate manufacturing of a piston having multiple piston channels. Alternatively, the piston 156 may be a unitary and integral construction.
A useful metric of a chamber may be a compression ratio (or its inverse, a expansion ratio) corresponding to a ratio of the internal volume of the chamber at is maximum and minimum points, which may correspond to a position of the piston at each end of its stroke. In various embodiments, the compression ratio or expansion ratio of a chamber may be determined by the location of the valves and diameter of the piston in the chamber. Segmenting the channel may be useful, for example, for increasing or tuning an effective compression and/or expansion ratio of one or more of the chambers for a given interior volume or piston stroke. For example, with reference to
According to some embodiments, a dose adjustment member 139 can be included in the handle 104. The dose adjustment member 139 can be, for example, a removable component or a movable component (e.g., slidable, twistable, etc.) that is configured to permit adjustment of the compression ratio. For example, the dose adjustment member 139 may be a removable component in the interior cavity of the housing 112 that can be swapped by a user or during manufacturing to tune the length of travel of the piston to adjust the compression ratio, and thereby the dosage delivered at each piston stroke or button press. As another example, the dose adjustment member 139 can be coupled to a user interface components, such as a slider or twist mechanism on the handle, that is configured to move the dose adjustment member 139 to various positions along the inner cavity of the housing 112 to constrain the travel of the piston to change the length of the piston stroke to two or more different user defined dosage volumes.
It will be appreciated that while a pair of complementary compression/expansion chambers 164a,b and corresponding valves 172a,b are shown, in various embodiments more or fewer chambers or valves may be included, as appropriate. For example, by eliminating one or the other of the entry chamber 164a or exit chamber 164b, the cost and complexity of the device may be reduced. Control of fluid flow may be greater with an increased number of chambers and valves.
Referring again to
The piston 156 is biased to a position at an end of its stroke. This may also bias the button 136 to an upward or release position. In particular, a return spring 188 is included that biases the piston 156 towards the proximal end of the housing 112. The return spring 188 is implemented as a coil spring disposed around a shaft of the piston 156 and coupled between an axial surface of the housing and an axial surface 192 of the piston 156. To permit coupling in this fashion, the piston 156 includes a step disposed on its exterior surface, as shown in
It will also be appreciated that while a mechanical button is shown in various embodiments, the instrument 100 may additionally or alternatively employ any of a variety of other actuators, such as other mechanical actuators, electronic actuators, touch sensitive buttons, or the like.
As seen in the figures, the pre-fill component 300 can contain a pre-fill chamber 330 that provides a fluid compartment from which the fluid transfer mechanism can draw fluid. The pre-fill chamber 330 can be filled with a desired fluid by coupling a syringe 124 or other fluid source to the pre-fill component during a priming or initial stage prior to a procedure. The syringe may be then removed once the pre-fill chamber 330 is filled. The pre-fill component 300 may be useful to, for example, reduce a total length of the instrument 100 by allowing the fluid transfer mechanism to draw fluid from a smaller sized or lower volume fluid compartment than in configurations where the syringe or other larger fluid source is maintained attached to the device during a medical procedure.
Referring to
The pre-fill component 300 can also include another luer connector 350 (e.g., at a proximal end thereof) for connecting to the syringe 124 or other fluid source that is used to fill the pre-fill component with the desired volume of fluid. For example, the syringe 124 may be attached to the pre-fill component 300 via luer connector 350, and the plunger 120 of the syringe may be depressed to first fill the pre-fill chamber 330 with a volume of fluid. Further depression of the plunger 120 may be used to bypass the mechanism as described above (e.g., to fully prime the instrument).
The pre-fill component 300 includes a mechanism to maintain a seal within the pre-fill chamber 330 upon removal of the syringe. The mechanism may be useful to, for example, avoid the potential introduction of air bubbles within the chamber or mitigate other undesirable effects upon removal of the syringe.
The pre-fill component 300 can include a sealing member 320 and an interface member 310. The sealing member 320 is configured to seal the pre-fill chamber 330 and permit the pre-fill chamber 330 to be filled via a fill port 360 of the interface member 310. The interface member 310 provides an interface between the pre-fill chamber 330 and the syringe used to fill the pre-fill chamber, which can be attached to the connector 350 of the interface member 310. The mechanism can be positioned as shown in
The pre-fill component 300 can be configured as follows to facilitate isolation of the fill port 360. The sealing member 320 can be slidably disposed in the chamber body 340, such that it can translate axially along a longitudinal axis thereof (which can correspond to the longitudinal axis 160 of the handle). The sealing member 320 can be configured to seal the chamber, for example, via an outer O-ring 304 that is coupled between an outer surface of the sealing member 320 and an inner surface of the chamber body 340. The outer O-ring 304 can be fixed to an outer surface of the sealing member 320 or the inner surface of the chamber body 340.
The sealing member 320 can also be rotatably fixed with respect to the chamber body 340 and the handle. For example, the sealing member 320 can include one or more anti-rotation tabs 363, which can protrude radially outward from the sealing member 320. The anti-rotation tabs 363 can be slotted in longitudinal slots of the chamber body 340 to constrain rotational movement of the anti-rotation tabs 363 about the longitudinal axis against the longitudinal slots, while permitting axial translation of the anti-rotation tabs 363 along the longitudinal slots. It will be appreciated that this configuration can be reversed, such that the anti-rotation tabs 363 are included on the chamber body and protrude radially inward into longitudinal slots of the sealing member 320. Various other mechanisms can be used to constrain the movement as desired.
The interface member 310 includes the connector 350 at its proximal end for coupling to the fluid source, and a projection 314 at its distal end that extends through an opening in the sealing member 320. The fill port 360 is disposed on the projection 314, and configured as a side port positioned on a lateral side of the projection 314 proximal to the terminal end at the distalmost end of the projection 314. This configuration allows an inner O-ring 308, disposed between an inner surface of the sealing member 320 and an outer surface of the projection 314, to pass over the fill port 360 with relative movement between the sealing member 320 and the interface member 310, thereby sealing the fill port 360 from the pre-fill chamber 330 or permitting the fill port 360 to fluidly communicate with the pre-fill chamber 330 depending on the relative positions of the sealing member 320 and interface member 310. The fill port 360 can be coupled to the luer connector 350 via a lumen 311 extending partially through the interface member 310. The inner O-ring can, for example, be held in place via a hollow set screw 322 of the sealing member, located on a distal side of the inner O-ring 308, which can permit the projection 314 to extend therethrough. Alternatively, any other suitable mechanism can be used to hold the inner O-ring in place, such as, for example, a circumferential groove along the inner surface of the sealing member 320.
The interface member 310 can be translatably fixed relative to the handle and chamber body via a retention groove 333. A guide member 343, such as a set screw, can be positioned in the retention groove 333, and the retention groove can be configured as a circumferential groove on an outer surface of the interface member 310 to permit the rotation of the interface member 310 as the guide member slides along the circumferential groove. The retention groove 333 can have stops positioned at ends thereof that permit rotation of the interface member 310 within only a limited range of motion, such as 180 degrees, which corresponds to half of a circumference of the outer surface of the interface member 310, but prevent rotation of the interface member beyond that limited range of motion upon the guide member 343 abutting the stop at the end of the groove. It will be appreciated that this can be tuned to any other limited range of rotation desired.
Each of the sealing member 320 and the interface member 310 include complementary spiral ramps 390, 392, which are configured to mate with each other. For example, sealing member 320 can include a first spiral ramp 392 facing a proximal direction, and the interface member 310 can include a second spiral ramp 390 facing a distal direction. The mating spiral ramps are configured to urge the interface member 310 and the sealing member 320 apart from each other with relative rotation therebetween, thereby sliding the inner O-ring over the fill port 360 to isolate the fill port 360 from the pre-fill chamber. For example, as the mated spiral ramps 390, 392 slide over each other with rotation of the interface member 310, the longitudinal translation constraint of the interface member coupled with the rotational constraint of the sealing member 320 causes the spiral ramp 390 of the interface member 310 to drive the sealing member 320 in a distal direction to thereby slide the inner O-ring 308 over the fill port 360, as seen in
An operation of the pre-fill component may thus be as follows. First, a user may attach a syringe to the luer connector 350 of the interface member 310, by rotating the syringe about the longitudinal axis in a first direction (e.g., clockwise). The guide member 343 may abut against a first stop at a first end of the circumferential retention groove 333 to permit the syringe to be tightened against the luer connector 350 as it is rotated in the first direction.
Next, the user may depress the plunger of the syringe to deliver fluid into the pre-fill chamber 330 through the luer connector. The user may further depress the plunger to prime the fluid transfer mechanism downstream from the pre-fill chamber after the pre-fill chamber has been filled, where depression of the plunger bypasses the check valves in the fluid transfer mechanism.
Once the instrument is primed, the user may begin to remove the syringe by rotating the syringe in a second direction, opposite the first direction (e.g., counter-clockwise). The rotation to remove the syringe may have two phases.
During the first phase, the interface member 310 rotates together with the syringe, as the guide member slides along the retention groove away from the first stop, along the groove, and towards the second step. As the interface member 310 rotates about the longitudinal axis together with the syringe, the spiral ramp 392 of the interface member urges movement of the sealing member 320 distally along the longitudinal axis, causing the interface member 310 and the sealing member 320 to separate from each other until the inner O-ring 308 slides past the fill port 360 to isolate the fill port 360 from the pre-fill chamber 330, and thus isolate the pre-fill chamber 330 from the syringe. As the syringe has been rotating together with the interface member 310 thus far, the seal between the syringe and the luer connector 350 remains intact and no air is introduced into the device.
After the inner O-ring passes over the fill port 360, the interface member 310 reaches the end of its limited rotational travel as the guide member 343 abuts the second stop at the opposite end of the retention groove 333 from the first stop. After this, the second phase of rotation is reached. During this second phase, the further rotation of the syringe disconnects the syringe from the luer connector 350 of the interface member, as the interface member is constrained from further rotation by the second stop. As the fill port 360 is now isolated from the pre-fill chamber, any air introduced by the disconnection of the syringe is prevented from reaching the pre-fill chamber.
Finally, after the syringe has been removed, the user (e.g., surgeon or medical practitioner) may operate the fluid transfer mechanism to deliver doses of fluid from the pre-fill chamber. The sealing member 320 may operate as a plunger at this stage, where each dosage of fluid caused by actuating the button draws the sealing member 320 forward distally by an amount of one dosage volume unit.
Referring now to
At step 202, a user may attach a syringe 124 to the housing 112. The syringe 124 may be attached using a luer lock connector or other suitable connection interface, as described above. At this stage, the fluid transfer mechanism is in a steady state and no fluid is flowing through the fluid transfer mechanism.
At step 206, a user may prime the instrument 100. In particular, the plunger 120 of the syringe 124 may be depressed, or fluid 204 may otherwise be ejected from the syringe 124, which may cause a cracking pressure of each of the valves 172a-d to be exceeded and cause fluid to flow through each of the valves 172a-d, and through the entire housing 112, in the forward direction. Once fluid is ejected from the tool or tip of the instrument, air bubbles may be removed and the instrument may be primed for fluid delivery to the intended target site, as appropriate. Additionally or alternatively, a similar process of depressing the plunger 120 may be used to bypass the fluid transfer mechanism and deliver a steady dosage of fluid, as desired. In particular, a cracking pressure of each of the valves 172a-d may be configured to be exceeded upon a depression of the plunger 120. In the example shown, the syringe 124 remains attached to the instrument during the remainder of the procedure to supply the fluid 204 delivered by the piston pump mechanism. In other embodiments, priming the instrument 100 may fill a pre-fill chamber as described herein. This may allow the syringe 124 to be removed at this stage, as fluid 204 delivered during the procedure via the piston pump mechanism can be drawn from the pre-fill chamber in the remaining steps.
At step 210, a user may press the button, or a forward stroke of the piston 156 may be otherwise actuated. As shown in
At step 214, a user may release the button, or a backward stroke of the piston 156 may be otherwise initiated. As shown in
It will be appreciated that embodiments disclosed herein may be useful for medical and surgical procedures. There are numerous medical and surgical procedures in which it is desirable to cut and remove a strip of tissue of controlled width from the body of a human or veterinary patient. For example, it may sometimes be desirable to form an incision of a controlled width (e.g., an incision that is wider than an incision made by a typical scalpel, cutting blade or needle) in the eye, skin, mucous membrane, tumor, organ or other tissue or a human or animal. In addition, it may sometimes be desirable to remove a strip or quantity of tissue from the body of a human or animal for use as a biopsy specimen, for chemical/biological analysis, for retention or archival of DNA identification purposes, etc. In addition, some surgical procedures require removal of a strip of tissue of a known width from an anatomical location within the body of a patient.
One surgical procedure wherein a strip of tissue of a known width is removed from an anatomical location within the body of a patient is an ophthalmological procedure used to treat glaucoma. This ophthalmological procedure is sometimes referred to as a goniotomy. In a goniotomy procedure, a device that is operative to cut or ablate a strip of tissue of approximately 2-10 mm in length or more and about 50-230 μm in width is inserted into the anterior chamber of the eye and used to remove a full thickness strip of tissue from the trabecular meshwork. The trabecular meshwork is a loosely organized, porous network of tissue that overlies a collecting canal known as Schlemm's canal. A fluid, known as aqueous humor, is continually produced in the anterior chamber of the eye. In healthy individuals, aqueous humor flows through the trabecular meshwork, into Schlemm's canal and out of the eye through a series of ducts called collector channels. In patients who suffer from glaucoma, the drainage of aqueous humor from the eye may be impaired by elevated flow resistance through the trabecular meshwork, thereby resulting in an increase in intraocular pressure. The goniotomy procedure can restore normal drainage of aqueous humor from the eye by removing a full thickness segment of the trabecular meshwork, thus allowing the aqueous humor to drain through the open area from which the strip of trabecular meshwork has been removed.
Embodiments disclosed herein can be used for surgical medicinal intervention. For example, some embodiments relate to a microsurgical device and methods of its use for treatment of various medical conditions including but not limited to eye diseases, such as glaucoma, using minimally invasive surgical techniques. In some embodiments, the device may be a dual-blade device for cutting the trabecular meshwork (“TM”) in the eye. For example, the device may have a device tip providing entry into the Schlemm's canal via its size (i.e., for example, between approximately 0.2-0.3 mm width) and a configuration where the entry blade tip ramps upwardly providing a wedge or ramp-like action for cutting the TM. Alternatively, a single incision device tip such as a microvitreoretinal (“MVR”) blade (BD, Franklin Lakes, N.J., USA) or a cautery device tip such as a Trabectome® device may be used. In some embodiments, the tool section 102 of the device can include a cannula, a microcannula, or dual-blade tool having a lumen for delivering fluid such as, for example those described in U.S. Non-Provisional application Ser. No. 15/791,204, filed on Oct. 23, 2017, U.S. Non-Provisional application Ser. No. 15/389,328, filed on Dec. 22, 2016, U.S. Provisional Application No. 62/750,151, filed on Oct. 28, 2018, or U.S. Non-Provisional application Ser. No. 15/847,770, filed on Dec. 19, 2017, the entirety of each of which is incorporated herein by reference.
Turning now to
Referring now to
As further shown in
As shown in
A transition feature can be provided between the bottom surface 15 and the opposing sides 8, 9. For example, the bottom surface 15 can transition to the opposing sides 8, 9 with transition sections 28, 29, respectively. While chamfers are shown for transition sections 28, 29 in
Referring now to
Adjacent to the tip 6, the bottom surface 15 can provide a continuous (e.g., planar) portion 16 that is not interrupted by the recessed portion 40. The tip 6 can be separated from the recessed portion 40 by the continuous portion 16. Accordingly, the bottom surface 15 can include a planar distal portion and a non-planar proximal portion along the length thereof. The tip 6 and the region (e.g., continuous portion 16) immediately proximal to the tip 6 can be continuous, such that the recessed portion 40 does not intersect the tip 6. The recessed portion 40 can extend distally from the rear portion 7, for example, not farther than the opposing sides 8, 9 and/or the transition sections 28, 29. As shown in
The planar distal portion can provide an even surface to facilitate entry into tissue with the tip 6. The nonplanar proximal portion (e.g., the protrusions 38, 39 and the recessed portion 40) can interact with the Schlemm's canal during a procedure. As the platform 5 is moved, at least some of the tissue can be received within the recessed portion 40 between the protrusions 38, 39. The protrusions 38, 39 provide a smaller surface area for exposure to the tissue (e.g., Schlemm's canal). Accordingly, the nonplanar proximal portion of the bottom surface 15 provides greater maneuverability of the platform 5 as it moves along the tissue.
Referring now to
Referring now to
The device may be introduced through a clear corneal incision on an eye (e.g., incision size between 0.5 and 2.8 mm in width) and advanced through an anterior chamber of the eye, either across the pupil or across the body of the iris to engage the trabecular meshwork (TM) on the opposite side of the anterior chamber. The anterior chamber is filled with aqueous humor and, by way of example, may have a volume of approximately 0.25 milliliter (ml) and be approximately 3 millimeter (mm) deep. The anterior chamber may be filled with viscoelastic to replace the aqueous humor and stabilize the chamber during the procedure. Accordingly, approximately 0.25 ml may be injected into the chamber at this stage of the surgery. The viscoelastic may be injected into the anterior chamber using a syringe. In some embodiments, the viscoelastic may be injected by depressing plunger 120 or otherwise ejecting fluid from the syringe 124 in a manner that bypasses a fluid transfer mechanism in the instrument 100 (see
As shown for example in
In some cases, bleeding may occur during removal of the TM 20 or during the steps depicted in
The advancement of the platform 5 and the ramp 13 can proceed as the device advances clockwise or counterclockwise. The distal cutting portion is angled so that the dual blades are placed in optimum cutting position. This angle may be such that the cutting tip bends to conform to the area between Schwalbe's line and the scleral spur (SS), an area that encompasses SC. SC is narrow near the cornea and wider near the SS and thus an angled tip is best to present the tissue 20 to the two edges of the TM. The ramp 13 of the cutting tip may be angled so that the tissue 20 is constantly elevated towards the blade as the tip is advanced in circumferential pattern. Between the cutting tip and the first and second lateral blades 10, 11, the ramp 13 is shaped to avoid cutting tissue, such that the TM 20 that is elevated away from the outer wall of the Schlemm's canal 22 remains intact as it advances along the ramp 13. For example, the ramp 13 can include convex or beveled edges that are not sharp enough to cut the TM 20. Endoscopic visualization may also be used to guide the cutting. In some embodiments, the device of the present disclosure may be placed at the end of an endoscope, precluding the need for a gonio lens during treatment. In some embodiments, the device of the present disclosure may be place at the end of an endoscope and the TM may be engaged under direct visualization of the endoscope camera.
A reference to an element in the singular is not intended to mean one and only one unless specifically so stated, but rather one or more. For example, “a” module may refer to one or more modules. An element proceeded by “a,” “an,” “the,” or “said” does not, without further constraints, preclude the existence of additional same elements.
Headings and subheadings, if any, are used for convenience only and do not limit the invention. The word exemplary is used to mean serving as an example or illustration. To the extent that the term include, have, or the like is used, such term is intended to be inclusive in a manner similar to the term comprise as comprise is interpreted when employed as a transitional word in a claim. Relational terms such as first and second and the like may be used to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions.
Phrases such as an aspect, the aspect, another aspect, some aspects, one or more aspects, an implementation, the implementation, another implementation, some implementations, one or more implementations, an embodiment, the embodiment, another embodiment, some embodiments, one or more embodiments, a configuration, the configuration, another configuration, some configurations, one or more configurations, the subject technology, the disclosure, the present disclosure, other variations thereof and alike are for convenience and do not imply that a disclosure relating to such phrase(s) is essential to the subject technology or that such disclosure applies to all configurations of the subject technology. A disclosure relating to such phrase(s) may apply to all configurations, or one or more configurations. A disclosure relating to such phrase(s) may provide one or more examples. A phrase such as an aspect or some aspects may refer to one or more aspects and vice versa, and this applies similarly to other foregoing phrases.
A phrase “at least one of” preceding a series of items, with the terms “and” or “or” to separate any of the items, modifies the list as a whole, rather than each member of the list. The phrase “at least one of” does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, each of the phrases “at least one of A, B, and C” or “at least one of A, B, or C” refers to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.
It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of exemplary approaches. Unless explicitly stated otherwise, or the context clearly dictates otherwise, it is understood that the specific order or hierarchy of steps, operations, or processes may be performed in different order. Some of the steps, operations, or processes may be performed simultaneously. The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented. These may be performed in serial, linearly, in parallel or in different order.
In one aspect, a term coupled or the like may refer to being directly coupled. In another aspect, a term coupled or the like may refer to being indirectly coupled.
Terms such as top, bottom, front, rear, side, horizontal, vertical, and the like refer to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, such a term may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.
The disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the principles described herein may be applied to other aspects.
All structural and functional equivalents to the elements of the various aspects described throughout the disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for”.
The title, background, brief description of the drawings, abstract, and drawings are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that the description provides illustrative examples and the various features are grouped together in various implementations for the purpose of streamlining the disclosure. The method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The claims are hereby incorporated into the detailed description, with each claim standing on its own as a separately claimed subject matter.
The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language of the claims and to encompass all legal equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirements of the applicable patent law, nor should they be interpreted in such a way.
Claims
1. A medical instrument, comprising:
- an elongate tubular housing having a distal end and a proximal end;
- a tool section coupled to the distal end of the housing;
- an interior cavity disposed in the housing;
- a piston disposed in the interior cavity;
- a button coupled to the piston and disposed on the housing, wherein the button is configured to actuate the piston for pumping fluid through the housing;
- a fluid connector disposed at the proximal end of the housing;
- a fluid entry chamber disposed in the interior cavity on a proximal side of the piston;
- a fluid entry valve disposed on a proximal side of the fluid entry chamber, the fluid entry valve comprising a one-way valve that permits fluid flow to the fluid entry chamber from the fluid connector and prevents fluid flow out of the fluid entry chamber to the fluid connector;
- a fluid exit chamber disposed in the interior cavity on a distal side of the piston;
- a fluid exit valve disposed on a distal side of the fluid exit chamber; and
- a fluidic channel extending through the piston between a distal side of the fluid entry chamber and a proximal side of the fluid exit chamber, wherein the fluidic channel is segmented into a plurality of sub-channels, wherein each of the sub-channels terminates in a piston valve, wherein fluid exiting a first one of the sub-channels is configured to feed into a second one of the sub-channels.
2. The medical instrument of claim 1, further comprising:
- a pre-fill chamber;
- a sealing member configured to seal the pre-fill chamber; and
- an interface member having a proximal end configured to couple to a fluid source, a distal end configured to extend through the sealing member, and a fill port configured to deliver fluid from the fluid source to the pre-fill chamber,
- wherein rotation of the interface member relative to the sealing member is configured to urge movement of the sealing member to isolate the fill port from the pre-fill chamber.
3. The medical instrument of claim 1, further comprising:
- a pre-fill chamber;
- a sealing member configured to seal the pre-fill chamber, the sealing member being translatable along a longitudinal axis of the housing and rotatably fixed with respect to the housing, the sealing member having an opening extending therethrough, and a first spiral ramp; and
- an interface member having a proximal end, a distal end, a connector at the proximal end of the interface member configured to couple to a fluid source, a projection at the distal end of the interface member extending through the opening of the sealing member, a fill port on a lateral side of the projection, and a second spiral ramp configured to mate with the first spiral ramp of the sealing member, the interface member being rotatable about the longitudinal axis of the housing within a limited range of rotation, and translatably fixed along the longitudinal axis with respect to the housing,
- wherein rotation of the interface member within the limited range is configured to drive the sealing member distally along the longitudinal axis, via engagement between the first and second spiral ramps, to slide a seal past the fill port to isolate the fill port from the pre-fill chamber.
4. The surgical instrument of claim 1, further comprising a dose adjustment member coupled to the piston, wherein the dose adjustment member is adjustable to modify a length of travel of the piston and thereby change a volume of the fluid delivered upon the forward stroke of the piston.
5. The medical instrument of claim 1, wherein the elongate tubular housing has a lateral exterior surface that provides a grip for a human hand, and wherein the button is disposed on a lateral side of the elongate tubular housing.
6. The medical instrument of claim 1, wherein the button comprises a first sloped surface, wherein the piston comprises a second sloped surface, and wherein sliding engagement between the first sloped surface and the second sloped surface is configured to actuate a stroke of the piston.
7. The medical instrument of claim 1, wherein one of the button or the piston comprises a sloped surface, wherein the other of the button or the piston comprises a wheel, and wherein engagement between the sloped surface and the wheel is configured to actuate a stroke of the piston.
8. The medical instrument of claim 1,
- wherein a forward stroke of the piston causes compression of the fluid exit chamber and expansion of the fluid entry chamber.
9. The medical instrument of claim 8,
- wherein the compression of the fluid exit chamber is configured eject fluid from the fluid exit chamber to the tool section, and
- wherein the expansion of the fluid entry chamber is configured to draw fluid into the fluid entry chamber from a fluid source.
10. The medical instrument of claim 1,
- wherein the tool section comprises an ophthalmic blade at a distal end and a lumen;
- wherein the housing is configured to couple to a viscoelastic syringe; and
- wherein the piston is configured to transfer viscoelastic fluid from the viscoelastic syringe to the lumen.
11. The medical instrument of claim 10,
- wherein the ophthalmic blade comprises a dual-blade tip for incising a trabecular meshwork.
12. The medical instrument of claim 1, wherein the fluid connector is a luer lock connector configured to attach to a fluid source.
13. The medical instrument of claim 1, wherein a backward stroke of the piston is configured to transfer fluid from the fluid entry chamber to the fluid exit chamber.
14. The medical instrument of claim 1, wherein the piston is biased towards the proximal end, wherein release of the button is configured to cause a backward stroke of the piston towards the proximal end.
15. The medical instrument of claim 1, further comprising:
- a lock mechanism configured to lock the piston in a forward position, wherein the lock mechanism comprises a stop member on the piston and a twistable member configured to abut the stop member.
16. The medical instrument of claim 1, further comprising:
- a lock mechanism configured to lock the piston in a forward position, wherein the lock mechanism comprises a tab on the button that is slidable into the housing to hold the button in a depressed position.
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Type: Grant
Filed: Dec 6, 2019
Date of Patent: Mar 16, 2021
Patent Publication Number: 20200108207
Assignee: NEW WORLD MEDICAL, INC. (Rancho Cucamonga, CA)
Inventors: Vijay R. Balan (Torrance, CA), Nico J. Slabber (Eastvale, CA)
Primary Examiner: Bhisma Mehta
Assistant Examiner: James D Ponton
Application Number: 16/706,538
International Classification: A61M 5/315 (20060101); A61M 5/31 (20060101); A61B 17/3211 (20060101);
